Idarucizumab reverses the blood-thinning effects of dabigatran

The FDA has approved the first reversal agent for a novel oral anticoagulant (NOAC) -- this one for dabigatran (Pradaxa), the agency announced.

Idarucizumab (Praxbind), which works by binding to dabigatran in the blood when given via intravenous injection, will be indicated for emergency situations prompting the need to reverse the drug's blood-thinning effects, the FDA said in a press release.

The reversal agent, marketed by Boehringer Ingelheim, was given the green light under the agency's accelerated approval program.

Approval was based on findings from two studies. In one trial completed in 283 healthy volunteers who weren't taking dabigatran for its anticoagulant effects, there was an immediate reduction in the amount of anticoagulant in the blood that lasted for at least 24 hours.

The most common side effect reported in that trial was headache, the FDA said.

The second study -- the RE-VERSE AD trial -- involved 123 patients regularly taking dabigatran who received the antidote because they had uncontrolled bleeding or needed emergency surgery.

That study found idarucizumab fully reversed dabigatran's blood-thinning effects in 89% of patients within 4 hours. The most common side effects were hypokalemia, confusion, constipation, fever, and pneumonia.

The FDA warned that reversing the effects of dabigatran exposes patients to the risk of blood clots and stroke from their underlying disease, and the product's labeling recommends that patients get back on their anticoagulant as soon as their healthcare provider determines that it's medically appropriate to do so.

Dabigatran was approved in 2010 for the prevention of stroke and blood clots in patients with atrial fibrillation, and for the prevention and treatment of deep venous thrombosis and pulmonary embolism.